A multicomponent family support intervention in intensive care units: study protocol for a multicenter cluster-randomized trial (FICUS Trial)

Rahel Naef, Miodrag Filipovic, Marie-Madlen Jeitziner, Stefanie von Felten, Judith Safford, Marco Riguzzi, Michael Rufer, Rahel Naef, Miodrag Filipovic, Marie-Madlen Jeitziner, Stefanie von Felten, Judith Safford, Marco Riguzzi, Michael Rufer

Abstract

Background: Family members of critically ill patients face considerable uncertainty and distress during their close others' intensive care unit (ICU) stay. About 20-60% of family members experience adverse mental health outcomes post-ICU, such as symptoms of anxiety, depression, and posttraumatic stress. Guidelines recommend structured family inclusion, communication, and support, but the existing evidence base around protocolized family support interventions is modest and requires substantiation.

Methods: To test the clinical effectiveness and explore the implementation of a multicomponent, nurse-led family support intervention in ICUs, we will undertake a parallel, cluster-randomized, controlled, multicenter superiority hybrid-type 1 trial. It will include eight clusters (ICUs) per study arm, with a projected total sample size of 896 family members of adult, critically ill patients treated in the German-speaking part of Switzerland. The trial targets family members of critically ill patients with an expected ICU stay of 48 h or longer. Families in the intervention arm will receive a family support intervention in addition to usual care. The intervention consists of specialist nurse support that is mapped to the patient pathway with follow-up care and includes psycho-educational and relationship-focused family interventions, and structured, interprofessional communication, and shared decision-making with families. Families in the control arm will receive usual care. The primary study endpoint is quality of family care, operationalized as family members' satisfaction with ICU care at discharge. Secondary endpoints include quality of communication and nurse support, family management of critical illness (functioning, resilience), and family members' mental health (well-being, psychological distress) measured at admission, discharge, and after 3, 6, and 12 months. Data of all participants, regardless of protocol adherence, will be analyzed using linear mixed-effects models, with the individual participant as the unit of inference.

Discussion: This trial will examine the effectiveness of the family support intervention and generate knowledge of its implementability. Both types of evidence are necessary to determine whether the intervention works as intended in clinical practice and could be scaled up to other ICUs. The study findings will make a significant contribution to the current body of knowledge on effective ICU care that promotes family participation and well-being.

Trial registration: ClinicalTrials.gov NCT05280691 . Prospectively registered on 20 February 2022.

Keywords: Anxiety (MeSH); Cluster-randomized controlled trial (non-MeSH); Depression (MeSH); Family (MeSH); Family nursing (MeSH); Intensive care (MeSH); Post-traumatic stress disorder (MeSH); Postintensive care syndrome – family (non-MeSH); Satisfaction with care (non-MeSH).

Conflict of interest statement

The authors declare that they have no competing interests.

© 2022. The Author(s).

Figures

Fig. 1
Fig. 1
Intervention mechanism
Fig. 2
Fig. 2
FSI program logic model
Fig. 3
Fig. 3
Family care pathway

References

    1. Eggenberger SK, Nelms TP. Being family: the family experience when an adult member is hospitalized with a critical illness. J Clin Nurs. 2007;16(9):1618–1628.
    1. Hopkins RO. Emotional processing/psychological morbidity in the ICU. In: Netzer G, editor. Families in the Intensive care unit: a guide to understanding, engaging, and supporting at the bedside. Cham: Springer Nature; 2018. pp. 31–48.
    1. Alfheim HB, Hofso K, Smastuen MC, Toien K, Rosseland LA, Rustoen T. Post-traumatic stress symptoms in family caregivers of intensive care unit patients: a longitudinal study. Intensive Crit Care Nurs. 2019;50:5–10.
    1. Minton C, Batten L, Huntington A. A multicase study of prolonged critical illness in the intensive care unit: families’ experiences. Intensive Crit Care Nurs. 2019;50:21–27.
    1. Turner-Cobb JM, Smith PC, Ramchandani P, Begen FM, Padkin A. The acute psychobiological impact of the intensive care experience on relatives. Psychol Health Med. 2016;21(1):20–26.
    1. Alfheim HB, Rosseland LA, Hofsø K, Småstuen MC, Rustøen T. Multiple symptoms in family caregivers of intensive care unit patients. J Pain Symptom Manage. 2018;55(2):387–394.
    1. Kentish-Barnes N, Chaize M, Seegers V, Legriel S, Cariou A, Jaber S, et al. Complicated grief after death of a relative in the intensive care unit. Eur Respir J. 2015;45(5):1341–1352.
    1. Inoue S, Hatakeyama J, Kondo Y, Hifumi T, Sakuramoto H, Kawasaki T, et al. Post-intensive care syndrome: its pathophysiology, prevention, and future directions. Acute Med Surg. 2019;6(3):233–246.
    1. Davidson JE, Jones C, Bienvenu OJ. Family responses to critical illness: postintensive care syndrome - family. Crit Care Med. 2012;40(2):618–624.
    1. Harvey MA, Davidson J. Long-term consequences of critical illness: a new opportunity for high-impact critical care nurses. Crit Care Nurse. 2011;31(5):12–15.
    1. van Beusekom I, Bakhshi-Raiez F, de Keizer NF, Dongelmans DA, van der Schaaf M. Reported burden on informal caregivers of ICU survivors: a literature review. Crit Care. 2016;20:16.
    1. Cattelan J, Castellano S, Merdji H, Audusseau J, Claude B, Feuillassier L, et al. Psychological effects of remote-only communication among reference persons of ICU patients during COVID-19 pandemic. J Intensive Care. 2021;9(1):5.
    1. Kentish-Barnes N, Cohen-Solal Z, Morin L, Souppart V, Pochard F, Azoulay E. Lived experiences of family members of patients with severe COVID-19 who died in intensive care units in France. JAMA Netw Open. 2021;4(6):e2113355.
    1. Netzer G, editor. Families in the intensive care unit: a guide to understanding, engaging, and supporting at the bedside. Springer Nature: Cham; 2018.
    1. Davidson JE, Aslakson RA, Long AC, Puntillo KA, Kross EK, Hart J, et al. Guidelines for family-centered care in the neonatal, pediatric, and adult ICU. Crit Care Med. 2017;45(1):103–128.
    1. Rawal G, Yadav S, Kumar R. Post-intensive care syndrome: an overview. J Translat Internal Med. 2017;5(2):90–92.
    1. Azoulay É, Curtis JR, Kentish-Barnes N. Ten reasons for focusing on the care we provide for family members of critically ill patients with COVID-19. Intensive Care Med. 2021;47(2):230–233.
    1. Montauk TR, Kuhl EA. COVID-related family separation and trauma in the intensive care unit. Psychol Trauma. 2020;12(S1):S96–SS7.
    1. Zante B, Erne K, Grossenbacher J, Camenisch SA, Schefold JC, Jeitziner MM. Symptoms of post-traumatic stress disorder (PTSD) in next of kin during suspension of ICU visits during the COVID-19 pandemic: a prospective observational study. BMC Psychiatry. 2021;21(1):477.
    1. Gerritsen RT, Hartog CS, Curtis JR. New developments in the provision of family-centered care in the intensive care unit. Intensive Care Med. 2017;43(4):550–553.
    1. Lee HW, Park Y, Jang EJ, Lee YJ. Intensive care unit length of stay is reduced by protocolized family support intervention: a systematic review and meta-analysis. Intensive Care Med. 2019;45(8):1072–1081.
    1. Goldfarb MJ, Bibas L, Bartlett V, Jones H, Khan N. Outcomes of patient- and family-centered care interventions in the ICU: a systematic review and meta-analysis. Crit Care Med. 2017;45(10):1751–1761.
    1. Scheunemann LP, McDevitt M, Carson SS, Hanson LC. Randomized, controlled trials of interventions to improve communication in intensive care: a systematic review. Chest. 2011;139(3):543–554.
    1. Kiwanuka F, Sak-Dankosky N, Alemayehu YH, Nanyonga RC, Kvist T. The evidence base of nurse-led family interventions for improving family outcomes in adult critical care settings: a mixed method systematic review. Int J Nurs Stud. 2022;125:104100.
    1. Xyrichis A, Fletcher S, Philippou J, Brearley S, Terblanche M, Rafferty AM. Interventions to promote family member involvement in adult critical care settings: a systematic review. BMJ Open. 2021;11(4):e042556.
    1. Zante B, Camenisch SA, Schefold JC. Interventions in post-intensive care syndrome-family: a systematic literature review. Crit Care Med. 2020;48(9):e835–ee40.
    1. Iftikhar IH, Goldfarb M. Effect of patient- and family-centered care interventions on ICU length of stay. Crit Care Med. 2018;46:e186–7.
    1. Shelton W, Moore CD, Socaris S, Gao J, Dowling J. The effect of a family support intervention on family satisfaction, length-of-stay, and cost of care in the intensive care unit. Crit Care Med. 2010;38(5):1315–1320.
    1. White DB, Cua SM, Walk R, Pollice L, Weissfeld L, Hong S, et al. Nurse-led intervention to improve surrogate decision making for patients with advanced critical illness. Am J Crit Care. 2012;21(6):396–409.
    1. White DB, Angus DC, Shields AM, Buddadhumaruk P, Pidro C, Paner C, et al. A randomized trial of a family-support intervention in intensive care units. N Engl J Med. 2018;378(25):2365–2375.
    1. Moore CD, Bernardini GL, Hinerman R, Sigond K, Dowling J, Wang DB, et al. The effect of a family support intervention on physician, nurse, and family perceptions of care in the surgical, neurological, and medical intensive care units. Crit Care Nurs Q. 2012;35(4):378–387.
    1. Naef R, von Felten S, Petry H, Ernst J, Massarotto P. Impact of a nurse-led family support intervention on family members’ satisfaction with intensive care and psychological wellbeing: a mixed-methods evaluation. Aust Crit Care. 2021;34(6):594–603.
    1. Naef R, Massarotto P, Petry H. Families’ and health professionals’ experience with a nurse-led family support intervention in ICU: a qualitative evaluation study. Intensive Crit Care Nurs. 2020;61:102916.
    1. Torke AM, Wocial LD, Johns SA, Sachs GA, Callahan CM, Bosslet GT, et al. The family navigator: a pilot intervention to support intensive care unit family surrogates. Am J Crit Care. 2016;25(6):498–507.
    1. Taylor SP, Short RT, Asher AM, Muthukkumar R, Sanka P. Family engagement navigators: a novel program to facilitate family-centered care in the intensive care unit during COVID-19. NEJM Catalyst. 2020. 10.1056/CAT.20.0396.
    1. Lopez-Soto C, Bates E, Anderson C, Saha S, Adams L, Aulakh A, et al. The role of a liaison team in ICU family communication during the COVID 19 pandemic. J Pain Symptom Manage. 2021;62(3):e112–9.
    1. Keen A, George A, Stuck BT, Snyder C, Fleck K, Azar J, et al. Nurse perceptions of a nurse family liaison implemented during the COVID-19 pandemic: a qualitative thematic analysis. Intensive Crit Care Nurs. 2021;70:103185.
    1. Curtis JR, Treece PD, Nielsen EL, Gold J, Ciechanowski PS, Shannon SE, et al. Randomized trial of communication facilitators to reduce family distress and intensity of end-of-life care. Am J Respir Crit Care Med. 2016;193(2):154–162.
    1. Kentish-Barnes N, Chevret S, Valade S, Jaber S, Kerhuel L, Guisset O, et al. A three-step support strategy for relatives of patients dying in the intensive care unit: a cluster randomised trial. Lancet. 2022;399:656–664.
    1. Liu K, Nakamura K, Katsukawa H, Nydahl P, Ely EW, Kudchadkar SR, et al. Implementation of the ABCDEF bundle for critically Ill ICU patients during the COVID-19 pandemic: a multi-national 1-day point prevalence study. Front Med. 2021;8:735860.
    1. Kleinpell R, Heyland DK, Lipman J, Sprung CL, Levy M, Mer M, et al. Patient and family engagement in the ICU: report from the task force of the World Federation of Societies of Intensive and Critical Care Medicine. J Crit Care. 2018;48:251–256.
    1. Landes SJ, McBain SA, Curran GM. An introduction to effectiveness-implementation hybrid designs. Psychiatry Res. 2019;280:112513.
    1. Chan A-W, Tetzlaff JM, Gøtzsche PC, Altman DG, Mann H, Berlin JA, et al. SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials. BMJ. 2013;346:e7586.
    1. Pandya-Wood R, Barron DS, Elliott J. A framework for public involvement at the design stage of NHS health and social care research: time to develop ethically conscious standards. Res Involve Engage. 2017;3(1):6.
    1. Burns KEA, Devlin JW, Hill NS. Patient and family engagement in designing and implementing a weaning trial: a novel research paradigm in critical care. Chest. 2017;152(4):707–711.
    1. Greenhalgh T, Hinton L, Finlay T, Macfarlane A, Fahy N, Clyde B, et al. Frameworks for supporting patient and public involvement in research: systematic review and co-design pilot. Health Expect. 2019;22(4):785–801.
    1. Marshall JC, Bosco L, Adhikari NK, Connolly B, Diaz JV, Dorman T, et al. What is an intensive care unit? A report of the task force of the World Federation of Societies of Intensive and Critical Care Medicine. J Crit Care. 2017;37:270–276.
    1. Calvert M, Kyte D, Mercieca-Bebber R, Slade A, Chan AW, King MT, et al. Guidelines for inclusion of patient-reported outcomes in clinical trial protocols: the SPIRIT-PRO Extension. Jama. 2018;319(5):483–494.
    1. Movsisyan A, Arnold L, Evans R, Hallingberg B, Moore G, O’Cathain A, et al. Adapting evidence-informed complex population health interventions for new contexts: a systematic review of guidance. Implement Sci. 2019;14(1):105.
    1. Doane GH, Varcoe C. Family nursing as relational inquiry: developing health-promoting practice. Philadelphia: Lippincott Williams & Wilkins; 2005.
    1. Gottlieb LN. Strengths-based nursing care: health and healing for person and family: Springer Publishing Company; 2012.
    1. Rolland JS, Emanuel LL, Torke AM. Applying a family systems lens to proxy decision making in clinical practice and research. Fam Syst Health. 2017;35(1):7–17.
    1. Shajani Z, Snell D. Wright & Leahey’s nurses and families: a guide to family assessment and intervention. 7. Davis: F. A; 2019.
    1. Hartmann M, Bazner E, Wild B, Eisler I, Herzog W. Effects of interventions involving the family in treatment of adult patients with chronic diseases: a meta-analysis. Psychother Psychosom. 2010;79(3):136–148.
    1. Östlund U, Persson C. Examining family responses to family systems nursing interventions: an integrative review. J Fam Nurs. 2014;20(3):259–286.
    1. Mahrer-Imhof R, Bruylands M. Is it beneficial to involve family members? A literature review to psychosocial interventions in family-centred nursing [German] Pflege. 2014;27(5):285–296.
    1. Chesla CA. Do family interventions improve health? J Fam Nurs. 2010;16(4):355–377.
    1. International Family Nursing Association . Position statement on advanced competencies for family nursing. 2017.
    1. Sidani S, Braden CJ. Design, evaluation, and translation of nursing interventions. Chichester: Wiley-Blackwell; 2011.
    1. Albers B, Metz A, Burke K. Implementation support practitioners – a proposal for consolidating a diverse evidence base. BMC Health Serv Res. 2020;20(1):368.
    1. Baker R, Camosso-Stefinovic J, Gillies C, Shaw EJ, Cheater F, Flottorp SA, et al. Tailored interventions to address determinants of practice. Cochrane Database Syst Rev. 2015;4:CD005470.
    1. Powell BJ, Beidas RS, Lewis CC, Aarons GA, McMillen JC, Proctor EK, et al. Methods to improve the selection and tailoring of implementation strategies. J Behav Health Serv Res. 2017;44(2):177–194.
    1. Padilla Fortunatti C, Munro CL. Factors associated with family satisfaction in the adult intensive care unit: a literature review. Aust Crit Care. 2021;31(5):318–24.
    1. Scott P, Thomson P, Shepherd A. Families of patients in ICU: a scoping review of their needs and satisfaction with care. Nursing Open. 2019;6(3):698–712.
    1. van den Broek JM, Brunsveld-Reinders AH, Zedlitz AM, Girbes AR, de Jonge E, Arbous MS. Questionnaires on family satisfaction in the adult ICU: a systematic review including psychometric properties. Crit Care Med. 2015;43(8):1731–1744.
    1. Harrison DA, Ferrando-Vivas P, Wright SE, McColl E, Rowan KM, Investigators FS. Psychometric assessment of the family satisfaction in the intensive care unit (FS-ICU-24) questionnaire among family members of patients admitted to adult general ICUs in the United Kingdom. Intensive Care Med Exp. 2015;3(Suppl 1):A152.
    1. Stricker KH, Niemann S, Bugnon S, Wurz J, Rohrer O, Rothen HU. Family satisfaction in the intensive care unit: cross-cultural adaptation of a questionnaire. J Crit Care. 2007;22(3):204–211.
    1. Cameron JI, Chu LM, Matte A, Tomlinson G, Chan L, Thomas C, et al. One-year outcomes in caregivers of critically ill patients. N Engl J Med. 2016;374(19):1831–1841.
    1. Stepanovic K, Van J, Jackson JJ. Family psychological morbidity after the intensive care unit. In: Netzer G, editor. Families in the intensive care unit: a guide to understanding, engaging, and supporting at the bedside. Cham: Springer Nature; 2018. pp. 49–60.
    1. Kerry SM, Bland JM. Sample size in cluster randomisation. Bmj. 1998;316(7130):549.
    1. Hemming K, Eldridge S, Forbes G, Weijer C, Taljaard M. How to design efficient cluster randomised trials. BMJ. 2017;358:j3064.
    1. Kleinman K, Moyer J, Reich N, Obeng D. clusterPower: power calculations for cluster-randomized and cluster-randomized crossover trials. R package version 0.6.111. 2017.
    1. Fabbro T. sse: sample size estimation. R package version 0.7-13. 2019.
    1. Esserman D, Allore HG, Travison TG. The method of randomization for cluster-randomized trials: challenges of including patients with multiple chronic conditions. Int J Stat Med Res. 2016;5(1):2–7.
    1. Ivers NM, Halperin IJ, Barnsley J, Grimshaw JM, Shah BR, Tu K, et al. Allocation techniques for balance at baseline in cluster randomized trials: a methodological review. Trials. 2012;13:120.
    1. Jin M, Polis A, Hartzel J. R package ‘Minirand’. 0.1.3 ed: CRAN; 2020.
    1. Hwang DY, El-Kareh R, Davidson JE. Implementing intensive care unit family-centered care: resources to identify and address gaps. AACN Adv Crit Care. 2017;28(2):148–154.
    1. Hwang DY, Yagoda D, Perrey HM, Tehan TM, Guanci M, Ananian L, et al. Assessment of satisfaction with care among family members of survivors in a neuroscience intensive care unit. J Neurosci Nurs. 2014;46(2):106–116.
    1. Institute for Healthcare Improvement . Patient- and family-centered care organizational self-assessment tool. 2013.
    1. Zill J, Christalle E, Müller E, Härter M, Dirmaier J, Scholl I. Measurement of physician-patient communication—a systematic review. PLoS One. 2014;9(12):e112637.
    1. Bieber C, Müller KG, Nicolai J, Hartmann M, Eich W. How does your doctor talk with you? Preliminary validation of a brief patient self-report questionnaire on the quality of physician-patient interaction. J Clin Psychol Med Settings. 2010;17(2):125–136.
    1. Bruce E, Dorell A, Lindh V, Erlingsson C, Lindkvist M, Sundin K. Translation and testing of the Swedish version of Iceland-Family Perceived Support Questionnaire with parents of children with congenital heart defects. J Fam Nurs. 2016;22(3):298–320.
    1. Sveinbjarnardottir EK, Svavarsdottir EK, Hrafnkelsson B. Psychometric development of the Iceland-Family Perceived Support Questionnaire (ICE-FPSQ) J Fam Nurs. 2012;18(3):328–352.
    1. Sousa VD, Rojjanasrirat W. Translation, adaptation and validation of instruments or scales for use in cross-cultural health care research: a clear and user-friendly guideline. J Eval Clin Pract. 2011;17(2):268–274.
    1. Mansfield AK, Keitner GI, Dealy J. The family assessment device: an update. Fam Process. 2015;54(1):82–93.
    1. Epstein N, Baldwin L, Bishop D. The McMaster Family Assessment Device. J Marital Fam Ther. 1983;9(2):171–180.
    1. Beierlein V, Bultmann JC, Möller B, von Klitzing K, Flechtner H-H, Resch F, et al. Measuring family functioning in families with parental cancer: reliability and validity of the German adaptation of the Family Assessment Device (FAD). J Psychosom Res. 2016;93:110–7
    1. Staccini L, Tomba E, Grandi S, Keitner GI. The evaluation of family functioning by the family assessment device: a systematic review of studies in adult clinical populations. Fam Process. 2015;54(1):94–115.
    1. Smith BW, Dalen J, Wiggins K, Tooley E, Christopher P, Bernard J. The brief resilience scale: assessing the ability to bounce back. Int J Behav Med. 2008;15(3):194–200.
    1. Bluth K, Eisenlohr-Moul TA. Response to a mindful self-compassion intervention in teens: a within-person association of mindfulness, self-compassion, and emotional well-being outcomes. J Adolesc. 2017;57:108–118.
    1. Romcevich LE, Reed S, Flowers SR, Kemper KJ, Mahan JD. Mind-body skills training for resident wellness: a pilot study of a brief mindfulness intervention. J Med Educ Curric Dev. 2018;5:1–10.
    1. Diener E, Emmons RA, Larsen RJ, Griffin S. The Satisfaction With Life Scale. J Pers Assess. 1985;49(1):71–75.
    1. Pavot W, Diener E. The Satisfaction With Life Scale and the emerging construct of life satisfaction. J Positive Psychol. 2008;3(2):137–152.
    1. Bech P, Olsen LR, Kjoller M, Rasmussen NK. Measuring well-being rather than the absence of distress symptoms: a comparison of the SF-36 Mental Health subscale and the WHO-Five Well-Being Scale. Int J Methods Psychiatr Res. 2003;12(2):85–91.
    1. Eurofund. European Quality of Life Survey 2016. Luxembourg: Publications Office of the European Union; 2017.
    1. Topp CW, Østergaard SD, Søndergaard S, Bech P. The WHO-5 Well-Being Index: a systematic review of the literature. Psychother Psychosom. 2015;84(3):167–176.
    1. Rabin R, de Charro F. EQ-5D: a measure of health status from the EuroQol Group. Ann Med. 2001;33(5):337–343.
    1. Donovan KA, Grassi L, McGinty HL, Jacobsen PB. Validation of the Distress Thermometer worldwide: state of the science. Psychooncology. 2014;23(3):241–250.
    1. Garrubba M. Use of Distress Thermometers in settings outside of oncology Centre for Clinical Effectiveness: Monash Health. 2019.
    1. Mehnert A, Müller D, Lehmann C, Koch U. Die deutsche Version des NCCN Distress-Thermometers. Zeitschrift für Psychiatrie, Psychol und Psychother. 2006;54(3):213–223.
    1. Zwahlen D, Hagenbuch N, Carley MI, Recklitis CJ, Buchi S. Screening cancer patients’ families with the Distress Thermometer (DT): a validation study. Psychooncology. 2008;17:959–66.
    1. Zwahlen D, Hagenbuch N, Jenewein J, Carley MI, Buchi S. Adopting a family approach to theory and practice: measuring distress in cancer patient-partner dyads with the Distress Thermometer. Psychooncology. 2011;20(4):394–403.
    1. McCormack HM, Horne DJ, Sheather S. Clinical applications of visual analogue scales: a critical review. Psychol Med. 1988;18(4):1007–1019.
    1. Ma X, Zhang J, Zhong W, Shu C, Wang F, Wen J, et al. The diagnostic role of a short screening tool--the Distress Thermometer: a meta-analysis. Support Care Cancer. 2014;22(7):1741–1755.
    1. Gessler S, Low J, Daniells E, Williams R, Brough V, Tookman A, et al. Screening for distress in cancer patients: is the Distress Thermometer a valid measure in the UK and does it measure change over time? A prospective validation study. Psychooncology. 2008;17(6):538–547.
    1. Ohnhäuser S, Wüller J, Foldenauer AC, Pastrana T. Changes in distress measured by the Distress Thermometer as reported by patients in home palliative care in Germany. J Palliat Care. 2018;33(1):39–46.
    1. Thalen-Lindstrom A, Larsson G, Hellbom M, Glimelius B, Johansson B. Validation of the Distress Thermometer in a Swedish population of oncology patients; accuracy of changes during six months. Eur J Oncol Nurs. 2013;17(5):625–663.
    1. Kentish-Barnes N, Lemiale V, Chaize M, Pochard F, Azoulay E. Assessing burden in families of critical care patients. Crit Care Med. 2009;37(10 Suppl):S448–S456.
    1. Maercker A, Schützwohl M. Erfassung von psychischen Belastungssfolgen: Die Impact of Event Skala-revidierte Version. Diagnostica. 1998;44:130–141.
    1. Weiss DS, Marmar CR. Assessing psychological trauma and PTSD. New York: Guilford; 1996.
    1. Thoresen S, Tambs K, Hussain A, Heir T, Johansen VA, Bisson JI. Brief measure of posttraumatic stress reactions: impact of Event Scale-6. Soc Psychiatry Psychiatr Epidemiol. 2010;45(3):405–412.
    1. McAdam JL, Puntillo K. Symptoms experienced by family members of patients in intensive care units. Am J Crit Care. 2009;18(3):200–209.
    1. Norton S, Cosco T, Doyle F, Done J, Sacker A. The Hospital Anxiety and Depression Scale: a meta confirmatory factor analysis. J Psychosom Res. 2013;74(1):74–81.
    1. Angst F, Verra ML, Lehmann S, Aeschlimann A. Responsiveness of five condition-specific and generic outcome assessment instruments for chronic pain. BMC Med Res Methodol. 2008;8:26.
    1. Herrmann C. International experiences with the Hospital Anxiety and Depression Scale--a review of validation data and clinical results. J Psychosom Res. 1997;42(1):17–41.
    1. Research Electronic Data Capture software: REDCap Consortium; 2022. . Accessed 22 Feb 2022.
    1. R Core Team . R: a language and environment for statistical computing Vienna, Austria: R Foundation for Statistical Computing. 2021.
    1. Leyrat C, Morgan KE, Leurent B, Kahan BC. Cluster randomized trials with a small number of clusters: which analyses should be used? Int J Epidemiol. 2018;47(3):1012.
    1. van Buuren S. Flexible imputation of missing data. 2nd ed: Chapman and Hall/CRC; 2018.
    1. Skivington K, Matthews L, Simpson SA, Craig P, Baird J, Blazeby JM, et al. A new framework for developing and evaluating complex interventions: update of Medical Research Council guidance. BMJ. 2021;374:n2061.
    1. Kynoch K, Chang A, Coyer F, McArdle A. The effectiveness of interventions to meet family needs of critically ill patients in an adult intensive care unit: a systematic review update. JBI Database System Rev Implement Rep. 2016;14(3):181–234.
    1. Mackie BR, Mitchell M, Marshall PA. The impact of interventions that promote family involvement in care on adult acute-care wards: an integrative review. Collegian. 2018;25(1):131–140.
    1. Deek H, Hamilton S, Brown N, Inglis SC, Digiacomo M, Newton PJ, et al. Family-centred approaches to healthcare interventions in chronic diseases in adults: a quantitative systematic review. J Adv Nurs. 2016;72(5):968–979.
    1. Hopkinson JB, Brown JC, Okamoto I, Addington-Hall JM. The effectiveness of patient-family carer (couple) intervention for the management of symptoms and other health-related problems in people affected by cancer: a systematic literature search and narrative review. J Pain Symptom Manage. 2012;43(1):111–142.
    1. Ågren S, Eriksson A, Fredrikson M, Hollman-Frisman G, Orwelius L. The health promoting conversations intervention for families with a critically ill relative: a pilot study. Intensive Crit Care Nurs. 2019;50:103–110.
    1. Steenbergen S, Rijkenberg S, Adonis T, Kroeze G, van Stijn I, Endeman H. Long-term treated intensive care patients outcomes: the one-year mortality rate, quality of life, health care use and long-term complications as reported by general practitioners. BMC Anesthesiol. 2015;15:142.
    1. Wintermann GB, Petrowski K, Weidner K, Strauß B, Rosendahl J. Impact of post-traumatic stress symptoms on the health-related quality of life in a cohort study with chronically critically ill patients and their partners: age matters. Crit Care. 2019;23(1):39.
    1. Torres J, Veiga C, Pinto F, Ferreira A, Sousa F, Jacinto R, et al. Caregiving burden: the impact of post intensive care syndrome. Intensive Care Med Exp. 2015;3(1):A967.
    1. Banno A, Hifumi T, Takahashi Y, Soh M, Sakaguchi A, Shimano S, et al. One-year outcomes of postintensive care syndrome in critically ill coronavirus disease 2019 patients: a single institutional study. Crit Care Explor. 2021;3(12):e0595.
    1. Weidman K, LaFond E, Hoffman KL, Goyal P, Parkhurst CN, Derry-Vick H, et al. Post-ICU syndrome in a cohort of COVID-19 survivors in New York City. Ann Am Thorac Soc. 2021. 10.1513/AnnalsATS.202104-520OC.
    1. Concannon TW, Grant S, Welch V, Petkovic J, Selby J, Crowe S, et al. Practical guidance for involving stakeholders in health research. J Gen Intern Med. 2019;34(3):458–463.
    1. Swiss Clinical Trial Organisation. Guide for researchers to address patient and public involvement (PPI) in clinical trials Bern: Swiss Clinical Trial Organisation & Swiss National Science Fund; 2021. . Accessed 22 Feb 2022.
    1. Mathie E, Smeeton N, Munday D, Rhodes G, Wythe H, Jones J. The role of patient and public involvement leads in facilitating feedback: “invisible work”. Res Involve Engage. 2020;6(1):40.
    1. Selman LE, Clement C, Douglas M, Douglas K, Taylor J, Metcalfe C, et al. Patient and public involvement in randomised clinical trials: a mixed-methods study of a clinical trials unit to identify good practice, barriers and facilitators. Trials. 2021;22(1):735.

Source: PubMed

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